Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
gliclazide, Quantity: 80 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica
Oral
100 tablets
(S4) Prescription Only Medicine
Indicated for the treatment of diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone.
Visual Identification: WHITE, ROUND FLAT-SIDED TABLETS WITH BEVELLED EDGES, ENGRAVED 'APO' OVER '80' ON ONE SIDE, CROSS-SCORED ON THE OTHER SIDE.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2002-06-17
APO-GLICLAZIDE TABLETS 1 APO-GLICLAZIDE UNCOATED TABLETS _Gliclazide _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about gliclazide. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Gliclazide belongs to a group of medicines called sulfonylureas. It is used to control blood glucose (sugar) in patients with Type II diabetes mellitus. This type of diabetes is also known as non- insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes. Gliclazide is used when diet and exercise are not enough to control your blood glucose. Gliclazide can be used alone or together with other medicines for treating diabetes. _HOW IT WORKS _ Glucose is used by the body as fuel, and all people have glucose circulating in their blood. In diabetes, levels of blood glucose are higher than is needed. This is called hyperglycaemia. Gliclazide lowers high blood glucose by increasing the amount of insulin produced by your pancreas. If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose). High blood glucose can lead to serious problems with our heart, circulation and/or kidneys. It is very important to control high blood glucose whether or not you feel unwell. This really helps to avoid serious long-term health problems, which can involve the heart, eyes, circulation, and/or kidneys. A SECTION AT THE END OF THIS LEAFLET CONTAINS ADVICE ABOUT RECOGNISING AND TREATING HYPERGLYCAEMIA. As with many medicines used for the tre read_full_document
1 AUSTRALIAN PRODUCT INFORMATION – APO-GLICLAZIDE (GLICLAZIDE) UNCOATED TABLET 1 NAME OF THE MEDICINE Gliclazide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains gliclazide 80 mg, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Uncoated tablet: Round, white, flat-sided tablets with bevelled edges, engraved “APO” over “80” on one side, cross-scored on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diabetes mellitus of the maturity onset type, which cannot be controlled by diet alone. 4.2 DOSE AND METHOD OF ADMINISTRATION For adult use only. Gliclazide should be taken with food because there is increased risk of hypoglycemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day and should not be increased. The daily dose may vary from 40 to 320 mg taken orally. The initial recommended dose is 40 mg (half tablet) daily even in elderly patients (≥ 65 years), and may be increased if necessary up to 320 mg (4 tablets) daily. Doses up to 160 mg daily may be taken in a single dose but preferably at the same time each morning. Doses in excess of 160 mg should be taken in divided doses in the morning and evening. In general, the dosage will depend on the severity of the glycaemia with ongoing adjustments should be made in order to obtain the optimal response at the lowest dosage. Treatment with gliclazide does not obviate the necessity of maintaining standard dietary regulations. 2 4.3 CONTRAINDICATIONS This medication is contraindicated in the following cases: • Hypersensitivity to gliclazide, other sulphonylureas, sulfonamides, or to any of the excipients (see 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICALS FORM). • Type I diabetes, diabetic keto-acidosis, diabet read_full_document